Niraparib (Zejula, GlaxoSmithKline) has been approved by the National Institute for Health and Care Excellence (NICE) for England's Cancer Drugs Fund (CDF) for some women with advanced ovarian cancer.
The decision means the drug should also be available in Wales and Northern Ireland. Scotland has not yet made its decision.
The PARP inhibitor will be available to women with stage 3 or 4 high-grade epithelial ovarian, Fallopian tube, or primary peritoneal cancer, regardless of BRCA status, after response to first-line platinum-based chemotherapy.
PRIMA Trial
NICE made its decision based on evidence from the ongoing PRIMA clinical trial.
Median progression-free survival in PRIMA was 13.8 months with niraparib and 8.2 months with placebo
It isn't yet known if the treatment extends life.
The list price is £4500 for 56 100mg capsules before any confidential NHS discounts.
NICE said the drug was made available on the CDF rather than for routine use due to clinical uncertainty over cost-effectiveness.
'Major Milestone'
The charity Target Ovarian Cancer has described the drug as "game changing" and its Chief Executive, Annwen Jones, said in a statement: "Today’s announcement is a major milestone in the fight against ovarian cancer. With two thirds of women unfortunately diagnosed with later stage disease, it is absolutely crucial that more effective treatments are available.
"This is the biggest breakthrough in ovarian cancer drugs since the since the introduction of the chemotherapy drug paclitaxel – Taxol – in the 1990s."
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Cite this: Nicky Broyd. NICE Approves 'Game-changing' Ovarian Cancer Drug - Medscape - Jan 15, 2021.
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